1. Field of Invention
The present invention relates to drug composition for treating chronic liver diseases and its application, and more particularly to drug composition of anti-hepatic fibrosis and liver injury and its application.
2. Description of Related Arts
Liver cirrhosis is the end stage of many chronic liver diseases, and has the morphological character of diffuse liver fibrosis with abnormal node. Liver cirrhosis is a common disease in China, and is also a main disease causing death. China has high incidence of hepatitis B, in which up to 30 millions patients have chronic liver diseases, and 30% of them develop to be liver cirrhosis. There has been definite evidence showing the reversibleness of liver fibrosis or even liver cirrhosis. Interdiction, inhibition or reversal of liver fibrosis is an important objective for treating chronic liver disease. However, there is no chemical or biological agent of anti-hepatic fibrosis in clinical application which is approved by FDA.
The progress in international research is mainly manifested as deep studying on the pathogenesis. An academic authority of liver fibrosis in US, Professor Friedman, has pointed out that continuous specification of the mechanism of liver fibrosis makes effectively treating of anti-hepatic fibrosis possible, but treating of hepatic fibrosis is still a challenging task and there is no effective drug for anti-hepatic fibrosis, so that it requires long-term effort to prepare anti-fibrosis drugs which can be effectively applied to the liver without obvious toxicity.
Chinese patent CN1539483A, published on 2004 Oct. 27, discloses a traditional Chinese medicine for treating chronic liver disease and anti-hepatic fibrosis, belonging to the technical filed of traditional Chinese medicine, which consists of Saffron 3-9 shares, Gecko 3-9 shares, Salvia 4-18 shares, turtle shell 9-24 shares, astragalus 9-30 shares, red ginseng 3-9 shares, Angelica 1-6 shares, Chuanxiong 1-6 shares, Amomum 1-6 shares, bombys batryticatus 1-6 shares, panax notoginseng 3-9 shares, medlar 1-9 shares, radices saussureae 1-6, and is filtered, cleaned, crushed into fine powder, sifted, and equalized. Each 100 grams of powder is mixed with 100 grams of honey per to make pill, and then sterilized with cobalt-60. The invention has been clinically proven to be effective to chronic hepatitis and liver fibrosis, and total efficiency is up to 94%.
Chinese patent CN1985902A, published on 2007 Jun. 27, discloses a traditional Chinese medicine for treating chronic liver disease, prepared according to the principle of “monarch, minister, assistant and guide”. The monarch component is raw Atractylodes, and the minister components comprise American ginseng, Polyporus, Poria, and raw Astragalus. The assistant components comprise sarmentosum, snake tongue grass, and capillary artemisia; the guide components comprise Sunburn Gallus gallus domesticus, Salvia, red peony, white peony root. The weight proportion of each component is raw Atractylodes 5% to 18%, American ginseng 1% to 10%, Polyporus 1% to 15%, Poria 0% to 15%, raw Astragalus 5% to 20%, sarmentosum 10% to 50%, snake tongue grass 5% to 30%, capillary artemisia 1% to 15%, Sunburn Gallus gallus 1% to 10%, Salvia 0% to 15%, red peony 1% to 10%, white peony root 1% to 10%, the sum of each component is 100%.
Chinese patent CN101361782A, published on 2009 Feb. 11, discloses a medicine for treating chronic liver disease, adopting the active components or ingredients of the traditional Chinese medicines Cordyceps Polysaccharide, amygdalin, and Gypenosides of a specific ratio to form a drug composition having good efficacy against liver fibrosis and liver damage.
In recent years, the concept of combining disease and syndrome, and syndrome differentially under the guidance of integration concept in traditional Chinese medicine (systems approach), gradually shows clinical features and theoretical advantages to solve this problem, which can not only improve clinical symptoms and liver function, but also significantly improves quality of life of patients, and shows superiority in the inhibition of liver inflammation and fibrosis and promotion of liver fibrosis reversal, etc. In recent decades, the study of liver fibrosis in medicine has made remarkable progress in China. Since 2000, there have been Fufang-biejia-rangan film, Fuzhenghuayu capsules (tablets) and other national anti-fibrosis drugs used in clinical medicine, wherein Fuzhenghuayu film has been approved by the FDA in the United States to carry out phase II clinical trial of anti-hepatic fibrosis of hepatitis C. The effect of traditional Chinese medicine against liver fibrosis is achieved through multi-channel, multi-level effect, and thus showing a combined effect, adapted to the development of liver fibrosis in the complex pathological mechanisms, which is the advantage of integration concept in traditional Chinese medicine.
In past two decades, a number of domestic and international researches have been carried out for active components or ingredients in traditional Chinese medicine of anti-hepatic fibrosis, and some active components or ingredients of traditional Chinese medicine having effects of anti-hepatic fibrosis are found. However, both traditional Chinese herbal compound, and a single active ingredient, has their shortcomings. Due to the complex composition of traditional Chinese herbal compound, quality control difficulties, poor stability, it is one of the problems for internationalization of the traditional Chinese medicine. Single component or ingredient is often difficult to obtain a good effect, but effective dose may bring obvious side effects. Therefore, eliminating side effect but maintaining the advantage of treating complex diseases of the traditional Chinese medicine compound, is a major problem, as well as one important direction of developing traditional Chinese medicine for anti-hepatic fibrosis.